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NTD News for Africa
A randomised controlled clinical trial on the safety of co-administration of
albendazole, ivermectin and praziquantel in infected schoolchildren in
Uganda

Harriet Namwanje et al. Trans R Soc Trop Med Hyg 2011;105:181–8
Introduction
Parasitic helminth infections, including lymphatic filariasis (LF), schistosomiasis and soil-
transmitted helminthiasis (STH), are prevalent and often co-exist among poor populations in
the developing world. Schistosomiasis and STH have particularly high prevalence among
school-aged children, and LF is also more prevalent in this population than previously
thought. Ivermectin (IVM) and albendazole (ALB) are used in combination to treat LF;
praziquantel (PZQ) is used to treat schistosomiasis; and ALB (or mebendazole) is used to
treat STH. These drugs are delivered separately in two drug packages (IVM+ALB and
PZQ±ALB) in the current integrated national control programs on the neglected tropical
diseases (NTDs). Considering the co-endemicity of these three diseases, combining
treatment for simultaneous control of these diseases using a single-dose drug package
would minimize costs and increase coverage. Single-dose combination treatment is believed
to increase patient adherence, prove less difficult in terms of distribution and be more cost
effective. The aim of the study was therefore to test the safety of co-administration of ALB,
IVM and PZQ as a single-dose package in the treatment of children aged 5-18 with various
infection statuses with LF, schistosomiasis and STH.
Methods
The study was conducted in Kei subcounty, Yumbe District, which was chosen because it
had the highest prevalence of triple infection in Northern Uganda. The study sample
consisted of children between the ages of 5-18 from 9 schools. A sample of around 50
children was randomly selected for each infection status (48 with LF alone, 60 with
schistosomiasis alone, 41 with STH alone, 49 with LF + schistosomiasis and 37 with LF +
schistosomiasis + STH) from the total available children for all infectious statuses except
STH alone and LF + schistosomiasis + STH, for which the limited number of students meant
they were all enrolled in the study. Participants were randomized to the test group or
control group for each infection status. The test groups were given a single-dose drug
package (ALB+IVM+PZQ), in comparison to the control groups which were treated
according to the current treatment regimen specific to each infection status in the
integrated NTD control program. All children were given food prior to treatment. Post-
treatment, a pediatrician blinded to the treatment regimens monitored the potential adverse
drug reactions (ADR) and serious adverse effects (SAEs) in all children for 7 days. All
relevant symptoms were recorded at baseline to ensure that symptoms reported after drug
administration were due to the treatment. The efficacy of different regimens was also
monitored.
NTD News for Africa April 2011
Results
There were 235 schoolchildren enrolled in the study: 118 in the test groups and 117 in the
control groups. After 13 children were lost to follow-up, the remaining children (n=222, 130
boys and 92 girls) were treated as follows: 115 in the test groups and 107 in the control
groups. Among the participants, 69.9% had light, 24% had moderate and 6.2% had heavy
infection with schistosomiasis; all STH infections were light; and in 53 children with LF worm
density data, 75.5% had 1-200 microfilariae and 24.5% had 201-1500 microfilariae per µl
of blood. The study found no statistically significant differences between the reported ADRs
among the test and control groups over the 7-day follow-up period after treatment. No
children reported SAEs or serious ADRs following treatment. Percentage reduction of
microfilariae and egg counts after treatment was comparable in both groups. There were no
statistically significant differences in the mean intensity of infection between the test and
control groups in any of the infection status groups.
Discussion
Co-administration of ALB, IVM and PZQ in the treatment of children aged 5-18 co-infected
with LF, schistosomiasis and STH was safe among the participants in this study. Children
treated with triple combination therapy did not experience more ADRs than those treated
with the current NTD program regimen specific to each infection status. ADRs, for example
difficulty in breathing, diarrhea, vomiting and blood in stool, constitute one reason for low
MDA (mass drug administration) compliance. Therefore, though the incidence of ADRs may
not decrease, treating for all three diseases on one occasion means that persons treated will
experience side effects, if any, only once rather than each time they get treatment. This
may address the issue of persons declining further treatment after experiencing ADRs the
first time, thereby increasing treatment coverage. As the reduction in mean intensity was
the same among those receiving triple combination therapy and the conventional regimens,
the study results also indicate that combined therapy is equally efficacious. Study limitations
include the fact that the sample size was relatively small and the follow-up period was quite
short.
Editor’s Comments
The purpose of integration of the NTD control programs is to reduce the costs and increase
the coverage of the national control programs, taking advantage of the available effective
drugs. The current integrated NTD control programs through MDA are targeting five major
NTDs according to the World Health Organization preventive chemotherapy guidelines. In
the national integrated NTD control programs currently being implemented, the drugs used
for the five targeted diseases are normally distributed in three separate packages
(ALB+IVM, PZQ±ALB, and Zithromax®) with short intervals in between. This reduces the
possibility of cost reduction and increases the possibility of decreased MDA compliance.
The current study combined ALB, IVM and PZQ as a single-dose drug package for LF,
schistosomiasis and STH, and showed that this combined package was as safe and
efficacious as the normal drug regimens in school children with prior MDA activities. Such
drug combination has also been used in Nigeria and in Zanzibar in the control projects. In
addition, the International Trachoma Initiative has recently supported a study in Mali on the
safety of the combination of Zithromax® for trachoma with LF treatment. Therefore, such
studies are important in illustrating the safety and efficacy of combining multiple drugs in
NTD News for Africa April 2011
MDA, and have the potential to improve the cost-effectiveness in the integrated NTD control
programs. However, precautions must be taken to expand such multi-drug packages to
large-scale use in the national NTD control programs. Adoption of such drug combinations
should be considered carefully according to the local context. More in-depth training of
community drug distributors should be given to avoid confusion by drug distributors as
multiple drugs and multiple dose-poles are involved. More stringent monitoring mechanism
for side-effects need to be in place. In endemic areas without prior MDA activities or with
very high level intensity of multiple infections, such single-dose drug package for multiple
NTDs may not be used at the beginning of the program, and further studies in such areas
are needed.
Recommended readings
Mohammed KA, Haji HJ, Gabrielli AF, Mubila L, Biswas G, Chitsulo L, et al. Triple co-
administration of ivermectin, albendazole and praziquantel in Zanzibar: a safety study. PLoS
Negl Trop Dis
2008; 2:e171
Eigege A, Pede E, Miri E, Umaru J, Ogbu Pearce P, Jinadu MY, et al. Triple drug
administration (TDA), with praziquantel, ivermectin and albendazole, for the prevention of
three neglected tropical diseases
in Nigeria. Ann Trop Med Parasitol 2008; 102:177–9
NTD News for Africa is a monthly electronic newsletter whose aim is to
disseminate state-of-the-art research and policy papers to scientists, program
planners, policy makers, and opinion leaders working in the field of NTD control in
Africa. It is a joint initiative by Liverpool School of Tropical Medicine, Centre for
Neglected Tropical Diseases and Helen Keller International, Regional Office for
Africa. We encourage members of this network to suggest possible documents of
interest and to provide feedback on the articles selected. “NTD News for Africa” is
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NTD News for Africa April 2011

Source: http://www.hki.org/research/ntd_en_apr_2011.pdf

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